Product code QGM
- Device name
- Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4405
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.
- Source
- FDA openFDA device classification dataset